CS Imaging Suite 5314307

GUDID 60192155314308

CS Imaging Suite

CARESTREAM DENTAL LLC

General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software

• Primary Device ID: 60192155314308
• NIH Device Record Key: b083dfac-e1b8-45ce-94bf-010b76916baa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS Imaging Suite
• Version Model Number: CS Imaging Suite
• Catalog Number: 5314307
• Company DUNS: 019796106
• Company Name: CARESTREAM DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192155314308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141607

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-01-15

On-Brand Devices [CS Imaging Suite]

• 60192155500671: CS IMAGING 8 SUITE
• 60192155314308: CS Imaging Suite
• 60192155943010: CS IMAGING CLIENT SERVER SUITE